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NCT Number: NCT03010839

Cardiopulmonary Protective Effects of Modified Remote Ischaemic Preconditioning in Mitral Valve Replacement Surgery

During cardiac surgery with cardiopulmonary bypass , injury occurs to the heart muscle and the lung.The heart and lung injury is a serious complication ,which increases both mortality and morbidity of cardiac surgery .Remote ischemic preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive strategy.Recent some trials suggested that RIPC could provide myocardial protection by reducing serum cardiac biomarkers,however, more recent multicenter studies[9-11] had failed to show the protective effects of RIPC with respect to the troponin release and lung injury.

Remote ischemic preconditioning (RIPC) is reported to have the early-phase and delayed-phase organ protective effects, whether the modified RIPC protocol induced repeatedly has the cardiopulmonary protective effect is still uncertain.

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Key information

Conditions

Myocardial Injury Remote Ischemic Preconditioning

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

About this study

modified RIPC was induced at 24 h, 12 h and 1 h before surgery to reinforce the protective effects of RIPC.The single RIPC protocol was induced by three cycles of upper-limb ischemia, a standard blood-pressure cuff was placed on the ringt upper arm, then inflated the cuff to 200 mm Hg for 5 minutes, followed by 5 min of cuff deflation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing heart surgery on cardiopulmonary bypass
  • Patients aged 18 years to 80 years

Exclusion criteria

  • Inability to give informed consent
  • Cardiogenic shock
  • Cardiac arrest on current admission
  • Left ventricular ejection fraction less than 30%
  • Current atrial fibrillation
  • Preoperative use of inotropics or mechanical assist device
  • Patients with significant hepatic dysfunction (Prothrombin>2.0 ratio)
  • Patients with known renal failure with a GFR<30 mL/min/1.73 m2
  • Patients with significant pulmonary disease (FEV1<40% predicted)
  • Recent myocardial infarction (within 7 days)
  • Recent systemic infection or sepsis (within 7 days)
  • Severe stroke (within 2 months)
  • Significant peripheral arterial disease affecting the upper limbs
  • Previous serious psychiatric disorders (e.g. schizophrenia, dementia)
  • Surgeries: cardiac transplantation, concomitant carotid endarterectomy , previous heart surgery,off-pump surgery, emergency surgery

Treatment and study plan

Modified Remote Ischemic Preconditioning

Procedure

mRIPC will be induced at 24 h, 12 h and 1 h before surgery and once before induction of anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200mmHg

Other names: mRIPC

Control

Procedure

Control group witnout remote ischemic preconditioning

Primary outcomes

  1. Troponin I serum release over 24 hours after surgery

    Time frame: 24 hours post surgery

Secondary outcomes

  1. PaO2/FiO2 ratio over 24 hours after surgery

    Time frame: 24 hours post surgery

  2. salveolar-arterial oxygen gradient over 24 hours after surgery

    Time frame: 24 hours post surgery

  3. Inotrope score

    Time frame: 12 hours post surgery

Sponsors and collaborators

Lead sponsor

Xuzhou Medical University

Other

Registry information

Official study title

Cardiopulmonary Protection of Modified Remote Ischaemic Preconditioning in Mitral Valve Replacement Surgery

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 5, 2017
Registry last updated
Mar 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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